Director Technology Transfer

Summary:

The Director, Technology Transfer is responsible for defining and governing the end-to-end technology transfer approach for new and modified clinical assays from Research & Development into regulated clinical laboratory operations at Baylor Genetics. This role owns transfer process design, launch readiness criteria, transfer validation/bridging strategy, and cross-lab standardization to ensure robust, reproducible, and scalable launches. The position serves as a technical liaison between R&D, Clinical Laboratory Operations, Quality, Automation, and Platform/Systems to ensure assays are transferable and implemented consistently, with clear handoffs to operations for steady-state execution.

Qualifications/

Experience:

* Education:

BS or above in Molecular Biology, Genetics, Genomics, or related discipline.

* Experience:

* 8+ years in clinical laboratory assay development, technology transfer, or operations.

* 3+ years in a supervisory or leadership role.

* Demonstrated success transferring high-complexity molecular or NGS assays into CLIA‑certified and/or CAP‑accredited laboratories.

* Skills:

* CLIA/CAP regulatory requirements related to assay implementation, validation, SOPs, training, and QC.

* Assay validation principles (accuracy, precision, LOD, reportable range, reference range, QC).

* Change management and governance for process design updates (e.g., readiness criteria, design space parameters, transfer documentation inputs).

* Automation and scalability of wet‑lab workflows.

* Data review, troubleshooting, and root‑cause analysis.

Duties and Responsibilities:

* Technology Transfer & Assay Implementation

* Lead structured technology transfer of new and modified assays from R&D into clinical production.

* Define transfer scope, readiness criteria, acceptance requirements, and operational handoff.

* Provide operational and compliance input early in assay development to ensure downstream transferability.

* Review assay designs and provide feedback to R&D focused on scalability, robustness, and clinical feasibility.

* Ensure transferred assays meet clinical operational, QC, and compliance expectations prior to go‑live.

* Assay Validation Support

* Support clinical assay validations and revalidations, including protocol review, execution support, and data review.

* Provide technical expertise for validation activities.

* Partner with R&D, Quality and Laboratory Directors to ensure validation documentation is complete, accurate, and inspection‑ready.

* Support validation‑related troubleshooting and assay optimization as needed.

* Clinical Technical Support & Workflow Optimization

* Provide time-bound technical support during transfer, go-live, and defined post-launch hypercare windows; triage complex assay performance issues and route steady-state operational ownership to Lab Ops per established handoffs.

* Define technical requirements and acceptance criteria for critical reagents, controls, and lot qualifications needed for launch; partner with Lab Ops and Quality on execution in accordance with controlled documentation.

* Analyze launch and early post-launch performance to identify design gaps, recommend corrective design changes, and prevent recurrence; support root-cause analysis in partnership with Lab Ops and Quality.

* SOPs, Documentation & Compliance

* Provide design intent, workflow inputs, and technical content to Lab Affairs/Quality for SOPs and controlled documentation associated with newly transferred or modified assays.

* Partner with Lab Affairs to ensure controlled documentation is clear, standardized, and aligned with CAP/CLIA requirements and internal quality systems.

* Partner with Quality and Lab Affairs to support change control and inspection readiness for transferred assays; provide technical assessments and impact analyses for changes that affect the defined design space.

* Automation, Scale‑Up & Digital Enablement

* Partner with Automation and Platform/Systems to define requirements and ensure readiness for scalable, automated workflows to support clinical production.

* Identify and document opportunities to reduce manual handling, variability, and error risk through automation and systems…